Osimertinib

Drug Profile

Osimertinib

Alternative Names: AZD-9291; Mereletinib; TAGRISSO

Latest Information Update: 11 Apr 2017

Price : $50

At a glance

  • Originator AstraZeneca
  • Developer AstraZeneca; Eli Lilly; Incyte Corporation; Kyushu University; National Cancer Institute (USA)
  • Class Acrylamides; Aniline compounds; Antineoplastics; Dimethylamines; Indoles; Pyrimidines; Small molecules
  • Mechanism of Action Epidermal growth factor receptor antagonists; Protein tyrosine kinase inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Non-small cell lung cancer
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Non-small cell lung cancer
  • Phase II Carcinomatous meningitis
  • Phase I Solid tumours

Most Recent Events

  • 31 Mar 2017 The US FDA grants full approval for osimertinib tablet (80mg once-daily) in patients with EGFR T790M mutation-positive Non-small cell lung cancer (Second-line or greater therapy, Metastatic disease, Late-stage disease)
  • 31 Mar 2017 Updated adverse events data from the phase III Aura3 trial in Non-small cell lung cancer released by AstraZeneca
  • 27 Mar 2017 Registered for Non-small cell lung cancer (Late-stage disease, Second-line therapy or greater) through CFDA's Priority Review pathway in China (PO)
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